Abstract 16850: Effect of Alirocumab in Patients With Diabetic Dyslipidemia and Chronic Kidney Disease
Introduction: Patients with type 2 diabetes mellitus (T2DM) are predisposed to dyslipidemia and chronic kidney disease (CKD), which can progress to end-stage renal disease without treatment. Many T2DM patients do not attain LDL-C treatment goals with statins and may benefit from additional lipid-lowering therapies (LLT). This analysis evaluated CKD progression and LDL-C efficacy of the PCSK9 inhibitor alirocumab (ALI) in T2DM patients with vs without moderate CKD (mCKD).
Methods: Data were pooled from 8 Phase 3 ODYSSEY trials involving 1544 T2DM patients, of whom 174 were followed up to 104 weeks. Patients had mCKD (30 ≤ eGFR < 60 mL/min/1.73m2; n=228) or mild CKD/normal renal function (eGFR ≥ 60 mL/min/1.73m2; n=1316), on background statins ± other LLT. Two trials (n=879) compared ALI 150 mg Q2W vs placebo (PBO). Six (n=665) compared ALI 75 mg Q2W vs PBO or ezetimibe (EZE) with increase to ALI 150 mg Q2W at Week (W) 12 if LDL-C was ≥70 or ≥100 mg/dL at W8.
Results: Baseline characteristics (lipids, blood pressure, blood glucose) were similar in ALI vs control groups and by CKD status. No effect of ALI on eGFR was seen in either group when stratified by CKD status (Fig 1) or by baseline level of entry dipstick proteinuria. Proportional reductions in LDL-C, non-HDL-C and Lp(a) with ALI were similar regardless of CKD status (Fig 2); all were significant vs control except Lp(a) in mCKD patients for ALI 75/150 vs PBO. Incidence of adverse events did not differ between groups or CKD status; nasopharyngitis, upper respiratory and urinary tract infection were most common.
Conclusion: ALI was an effective and well-tolerated treatment for dyslipidemia in T2DM patients; no effect on CKD progression was observed.
Author Disclosures: J.P. Dwyer: Other Research Support; Modest; Bayer. Other Research Support; Significant; AstraZeneca. H.M. Colhoun: Research Grant; Modest; Roche, Pfizer, Eli Lily, Boehringer Ingelheim, AztraZeneca, Sanofi Aventis. Honoraria; Modest; Pfizer. Ownership Interest; Modest; Roche, Bayer. Consultant/Advisory Board; Significant; Pfizer, Sanofi Aventis, Regeneron, Novartis, Eli Lily. F.J. Tinahones: None. M. Bujas-Bobanovic: Employment; Significant; Sanofi. J. Mandel: Other; Significant; Contractor for Sanofi mandated by IviData Stats. M.J. Louie: Employment; Significant; Regeneron Pharmaceuticals, Inc. R.J. Samuel: Employment; Significant; Regeneron Pharmaceuticals, Inc. K.K. Ray: Research Grant; Significant; Sanofi, Regeneron, Amgen, Pfizer, MSD. Honoraria; Modest; Takeda, Sanofi, Amgen, Pfizer, Boehringer Ingelheim, Cipla, Algorithm. Consultant/Advisory Board; Modest; Sanofi-Regeneron, Amgen, Takeda, Astra Zeneca, Medco, Resverlogix, Abbvie, Kowa, Lilly, Boehringer Ingelheim. P.P. Toth: Speakers Bureau; Modest; Kowa, Novartis, Sanofi-Aventis. Consultant/Advisory Board; Modest; Merck, Regeneron, Sanofi-Aventis. Speakers Bureau; Significant; Amarin, Amgen, Merck, Regeneron. Consultant/Advisory Board; Significant; Amgen, Kowa, Regeneron, Merck. M. Banach: Research Grant; Modest; Valeant. Speakers Bureau; Modest; Abbott, Mylan, Abbott Vascular, Actavis, Akcea, Amgen, KRKA, MSD, Sanofi-Aventis. Consultant/Advisory Board; Modest; Abbott Vascular, Amgen, Daiichi Sankyo, Esperion, MSD, Resverlogix, Sanofi-Aventis.
- © 2016 by American Heart Association, Inc.